NCT01819675

Brief Summary

The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) over the brain can modulate the binding of neurotransmitter (GABA in this study) to its receptor using the special PET study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

2.9 years

First QC Date

March 19, 2013

Last Update Submit

June 26, 2017

Conditions

StrokeHemiplegia

Keywords

Neuronal plasticityNeurotransmitter agentsReceptors, neurotransmitterTranscranial magnetic stimulationStrokegamma-Aminobutyric Acid

Outcome Measures

Primary Outcomes (1)

  • [18F]flumazenil binding potential

    Immediately after rTMS session , PET image will be acquired. By using these images, \[18F\]flumazenil binding potential will be calculated in selected anatomical region up to 3 months

    up to 3 months

Secondary Outcomes (1)

  • Purdue pegboard test score

    Before rTMS (baseline) and average 2hours after rTMS

Study Arms (3)

High frequency (10Hz) rTMS

EXPERIMENTAL

\<high frequency rTMS parameters\> Intensity: 120% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 10Hz; Number of total stimuli: 750; Coil orientation: tangential to scalp

Device: High frequency rTMS

Low frequency (1Hz) rTMS

EXPERIMENTAL

\<low frequency rTMS parameters\> Intensity: 120% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1200; Coil orientation: tangential to the scalp

Device: Low frequency rTMS

Sham rTMS

SHAM COMPARATOR

\<Sham rTMS parameters\> Intensity: 120% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1200; Coil orientation: perpendicular to scalp

Device: Sham rTMS

Interventions

Low frequency rTMSDEVICE
Also known as: Magpro (low frequency)
Low frequency (1Hz) rTMS
High frequency rTMSDEVICE
Also known as: Magpro (high frequency)
High frequency (10Hz) rTMS
Sham rTMSDEVICE
Also known as: Magpro (sham)
Sham rTMS

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy people
  • yrs old
  • Right handedness
  • Written informed consent

You may not qualify if:

  • Previous medical diseases such as seizure, stroke, diabetes, hypertension.
  • Taking any drugs
  • Smoker
  • Pregnancy
  • Contraindication of PET or MRI
  • Stroke or any tumor in MRI
  • Metals objects in the head or eyes
  • Cardiac pacemaker or cochlear implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (5)

  • Ayache SS, Farhat WH, Zouari HG, Hosseini H, Mylius V, Lefaucheur JP. Stroke rehabilitation using noninvasive cortical stimulation: motor deficit. Expert Rev Neurother. 2012 Aug;12(8):949-72. doi: 10.1586/ern.12.83.

    PMID: 23002939BACKGROUND

  • Malenka RC, Bear MF. LTP and LTD: an embarrassment of riches. Neuron. 2004 Sep 30;44(1):5-21. doi: 10.1016/j.neuron.2004.09.012.

    PMID: 15450156BACKGROUND

  • Thickbroom GW. Transcranial magnetic stimulation and synaptic plasticity: experimental framework and human models. Exp Brain Res. 2007 Jul;180(4):583-93. doi: 10.1007/s00221-007-0991-3. Epub 2007 Jun 12.

    PMID: 17562028BACKGROUND

  • Yue L, Xiao-lin H, Tao S. The effects of chronic repetitive transcranial magnetic stimulation on glutamate and gamma-aminobutyric acid in rat brain. Brain Res. 2009 Mar 13;1260:94-9. doi: 10.1016/j.brainres.2009.01.009. Epub 2009 Jan 12.

    PMID: 19401169BACKGROUND

  • Trippe J, Mix A, Aydin-Abidin S, Funke K, Benali A. theta burst and conventional low-frequency rTMS differentially affect GABAergic neurotransmission in the rat cortex. Exp Brain Res. 2009 Dec;199(3-4):411-21. doi: 10.1007/s00221-009-1961-8.

    PMID: 19701632BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nam-Jong Paik, MD, PhD

    Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

KR(1)